MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM 10BAG 500CAS AP

Catalog Number 328868

Device Problems Delivered as Unsterile Product (1421); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 0.5ml 30ga 8mm 10bag 500cas ap caused a needle stick injury due to exposed needle.This was discovered before use.The following information was provided by the initial reporter: needle stick injury due to exposed insulin syringe needle.On (b)(6) 2020, one customer requested for bd insulin syringe 8mm 0.5ml 30g.Pharmacist went to the drawer to help the customers taking the items.Upon pulling several packs of the requested items from the drawer, the pharmacist got pricked at his finger by a bd insulin needle which was uncapped, the sharp end of the needle protruding out from the pack.The needle pack was intact but the cap for the needle had been removed.The other pharmacists in the store - had reported to bd immediately about the incident.Both pharmacists then took out all the other bd insulin syringes bags in the shelf, and discovered 3 more bags of different skus with defects: 2 bags with the orange caps detached and needles exposed, and 1 bag with the white cap detached.All bags are intact.As per needle stick injury sop, pharmacist reported leave to go for medical check-up with a specialist on (b)(6) 2020.

Manufacturer Narrative

H.6.Investigation: customer returned (10) 1/2cc, 8mm, 30g syringes in a sealed poly bag from lot # 8288949.Customer states that there was a needle stick injury due to an exposed insulin syringe needle.The returned poly bag was examined and exhibited one syringe with the shield off in the bag and the cannula exposed, which could lead to a needle stick.A review of the device history record was completed for batch# 8288949.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 8337913.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause: drop gate not firing all the time creating indexer jams.Correction: l2l dispatch # 46727 was created to adjust indexer guard.

Event Description

It was reported that syringe 0.5ml 30ga 8mm 10bag 500cas ap caused a needle stick injury due to exposed needle.This was discovered before use.The following information was provided by the initial reporter: needle stick injury due to exposed insulin syringe needle.On 7 jan 2020, one customer requested for bd insulin syringe 8mm 0.5ml 30g.Pharmacist went to the drawer to help the customers taking the items.Upon pulling several packs of the requested items from the drawer, the pharmacist got pricked at his finger by a bd insulin needle which was uncapped, the sharp end of the needle protruding out from the pack.The needle pack was intact but the cap for the needle had been removed.The other pharmacists in the store - had reported to bd immediately about the incident.Both pharmacists then took out all the other bd insulin syringes bags in the shelf, and discovered 3 more bags of different skus with defects: 2 bags with the orange caps detached and needles exposed, and 1 bag with the white cap detached.All bags are intact.As per needle stick injury sop, pharmacist reported leave to go for medical check-up with a specialist on 8 jan 2020.

• Brand Name: SYRINGE 0.5ML 30GA 8MM 10BAG 500CAS AP
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9641012
• MDR Text Key: 189460263
• Report Number: 1920898-2020-00049
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 328868
• Device Lot Number: 8288949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention